510(k) · Cleared
ClearedOartrac System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiadyne · NZT Dosimeter, Ionizing Radiation, Implanted
Cleared on Jul 22, 2014 as substantially equivalent to K083035 (Sicel Technologies, Inc., 2008) and 1 other predicate after a 78-day review. Its family tree reaches back 8 generations to 2001. 3 later devices descend from it.
- Decided
- Jul 22, 2014
- Review
- 78 days
- Class
- Class II
- Product code
- NZT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K011332 (2001). 15 ancestors in all, the oldest K925416 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
- 7 generations backK021463 Model 1133 Ivd PC VersionSun Nuclear Corp. · 2002
- 6 generations backK040687 Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004
- 5 generations backK052118 Dose Verification SystemSicel Technologies, Inc. · 2006
- 4 generations backK061051 Dose Verification System Patient Dosimetry System, Models DVS-I-11…Sicel Technologies, Inc. · 2006
- 3 generations backK071399 Dose Verification System Patient Dosimetry System, Model DVS-I-11…Sicel Technologies, Inc. · 2007
- 2 generations backK080004 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- 1 generation backK083035 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- This deviceK141154 Oartrac SystemRadiadyne · 2014
- Descendant · cites it directly · 2 of its ownK150719 OARtrac System with Skin SensorsRadiadyne, LLC · 2015
- Descendant · cites it directly · 1 of its ownK162954 OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK182395 OARtrac SystemRadialdyne, LLC · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011332 | RF-Ivd Wireless Dosimeter-Model 1133 | Sun Nuclear Corp. | 2001 | — |
| −7 | K021463 | Model 1133 Ivd PC Version | Sun Nuclear Corp. | 2002 | — |
| −6 | K040687 | Onedose Patient Dosimetry System | Sicel Technologies, Inc. | 2004 | — |
| −5 | K052118 | Dose Verification System | Sicel Technologies, Inc. | 2006 | — |
| −4 | K061051 | Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS… | Sicel Technologies, Inc. | 2006 | — |
| −3 | K071399 | Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS… | Sicel Technologies, Inc. | 2007 | — |
| −2 | K080004 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | 2008 | — |
| −1 | K083035 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | 2008 | — |
| 0 (this device) | K141154 | Oartrac System | Radiadyne | 2014 | — |
| +1 | K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | 2015 | — |
| +1 | K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | Radiadyne, LLC | 2017 | — |
| +2 | K182395 | OARtrac System | Radialdyne, LLC | 2019 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NZT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NZT device
- #1 K250083 PRO-DOSE Systemscore 10.1 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083035 | Dose Verification System Patient Dosimetry SystemSummary page 2…tantial Equivalence Discussion RadiaDyne has chosen two predicate devices in the 510(k) submission for its OARtracO System, the Sicel Dose Verification System (K083035) manufactured by Sicel Technologies and cleared under Product Code NZT and §892.5050, and its own Prostate Immobilizer… | 2008 |
| * | DEN130036 | Prostate Immobilizer Rectal Balloon Our reading of the summary gave K132194, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130036, Prostate Immobilizer Rectal Balloon (Radiadyne), granted Jan 28, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2014 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K150719 (Radiadyne, LLC, 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NZT devicesNZT Dosimeter, Ionizing Radiation, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NZT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NZT
Too few NZT 510(k)s in any year since 2007 to give a median.
Recalls per year · NZT
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NZT
No MAUDE report names NZT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 5 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OARtract System is specifically indicated for male prostate cancer treatment to measure photon beam therapy as an adjunct to treatment planning permitting measuremeni of in-viva radiation dose received on the anterior surface of a modified Prostate Immobilization Endorectal Balloon (ERB) device to monitor and verify the surrounding organs at risk, specifically the protatic rectal interface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141154: Oartrac System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026